Clinical Trials in the USA / NCT05870488
Active, not recruiting
Phase 4
iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction
NCT05870488 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Sacroiliac Joint DysfunctionSacroiliac; FusionSacroiliac DisorderSacroiliac Joint Pain
Investigational drug(s) / intervention(s)
Use of iFuse TORQ
Use of iFuse TORQ: Use of iFuse TORQ for the treatment of SI Joint dysfunction
Study summary
iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction (STACI) is a prospective, multicenter, study of SIJ fusion using the iFuse TORQ implant system.
Eligibility
Inclusion Criteria:
1. Age \> 21 at time of screening
2. Patient has lower back / buttock pain for at least 6 months inadequately responsive to non-surgical care
3. Diagnosis of sacroiliac joint dysfunction (degenerative sacroiliitis or sacroiliac disruption)
4. Baseline Oswestry Disability Index (ODI) score of at least 30%
5. Baseline SIJ pain score of at least 5 on 0-10 numerical rating scale
6. BMI \< 35
7. Patient has signed study-specific informed consent form
Exclusion Criteria:
1. ASA score 4 or 5
2. Severe back pain due to other causes, such as lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, and lumbar vertebral body fracture
3. Other known sacroiliac pathology such as: inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondyloarthropathy), tumor, infection, acute fracture
4. Cluneal neuralgia
5. Previous SIJ implant placement, including allograft
6. Anatomic anomalies/defects that would preclude safe and/or biomechanically acceptable device placement
7. History of recent (\<1 year) major trauma to pelvis
8. Previously diagnosed or suspected severe osteoporosis (defined as prior T-score \< -2.5 or history of osteoporotic fracture).
9. Chronic rheumatologic condition (e.g., rheumatoid arthritis)
10. Current diagnosis of fibromyalgia
11. Known allergy to titanium or titanium alloys
12. Current local or systemic infection that raises the risk of surgery
13. Patient currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation
14. Currently pregnant or planning pregnancy in the next 2 years (self-reported)
15. Patient is a prisoner or a ward of the state.
16. Known or suspected active drug or alcohol abuse, including opioids
17. Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation
18. Currently participating in another interventional clinical trial
Primary outcome measure(s)
- Change in SI joint pain measured by numerical rating scale (NRS) — At baseline and 6 months
Change in SI joint pain measured by NRS (0- no pain to 10- worst pain imaginable)
Trial sites (14)
| Facility | City | Region | Status |
|---|---|---|---|
| Napa Valley Orthopaedics | Napa | California | |
| Source Healthcare | Santa Monica | California | |
| Comprehensive Pain and Spine Specialists | Shelbyville | Indiana | |
| Ascentist Healthcare | Leawood | Kansas | |
| Crimson Pain Management | Overland Park | Kansas | |
| University of Kentucky | Lexington | Kentucky | |
| Clearway Pain | Annapolis | Maryland | |
| St Louis Pain Consultants | Chesterfield | Missouri | |
| Nevada Advanced Pain | Reno | Nevada | |
| Clinical Investigations | Edmond | Oklahoma | |
| Neurological Associates of Lancaster | Lancaster | Pennsylvania | |
| Advanced Pain Institute of Texas | Lewisville | Texas | |
| Anesis Spine & Pain Care | Renton | Washington | |
| Pro Spine and Pain | Milwaukee | Wisconsin |
More SI-BONE, Inc. trials in the USA
Innovative Spinopelvic Solutions With Real-World Evidence
Active, not recruiting
Pelvic Fixation and Fusion During Multilevel Spinal Surgery
Active, not recruiting
Other trials for the same condition
Sacroiliac Joint Fusion Intervention For Mobility, Pain Relief, and Lasting Improvement in Functional Recovery "SIMPLIFY"
Enrolling by invitation
Post-Market Clinical Study on a Modular SI Joint Fusion System
Active, not recruiting
Innovative Spinopelvic Solutions With Real-World Evidence
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05870488 on ClinicalTrials.gov ↗ ← All trials in the USA